The PDSA's New DSCSA Governance Proposal Explained

On March 25, 2019 the Prescription Drug Security Alliance (PDSA) published the first of three white papers that describe their proposal for establishing a new, non-profit governance organization that would be responsible for ensuring interoperability of the Drug Supply Chain Security Act (DSCSA) solutions. This first paper is called “A Proposal: Governance for DSCSA Phase II Interoperability”. In addition, PDSA also published another paper called “An Overview: PDSA Vision for Phase II Interoperability and Governance.” Both papers can be obtained here.

The PDSA organization is composed of more than 30 members of the US pharma supply chain and their industry associations, including manufacturers, wholesale distributors, third-party logistics providers, and pharmacies. These member organizations recognize the critical need for some level of governance to ensure the success of the overall industry in meeting the interoperability requirement of the DSCSA, beginning in November of 2023.

With this series of white papers, the PDSA seeks to stimulate and advance the stakeholder dialogue related to, and development of, a shared vision of DSCSA interoperability among the industry and the FDA. Once complete, the three papers will likely offer the broadest discussion and perhaps the most viable approach to industry self-governance of DSCSA solutions available. Industry self-governance is necessary because the DSCSA does not fund such a role for the FDA, and so it is left to the industry to work out, with the cooperation of the FDA.

The first paper lays out the organizational details of a proposed stand-alone non-profit governance organization that would be composed of industry stakeholders but would be independent of the PDSA and any other existing organization. This appears to have some parallels with the European Medicines Verification Organization (EMVO) that governs the system of repositories developed by the industry to meet the Falsified Medicines Directive (FMD) there. One difference is that the creation of the EMVO was specifically mandated by the FMD Delegated Regulation. The DSCSA has no such mandate but the PDSA clearly recognizes the critical need for one.

In November of 2023, the DSCSA mandates that all members of the US pharma supply chain exchange DSCSA transaction data “[…]in a secure, interoperable, electronic manner,” but the text fails to provide guidance on how that can be accomplished. The PDSA has recognized that this requirement will only be accomplished through a concerted effort by the industry. The recently published white papers explain their position and the governance organization they propose.

This is an important event for stakeholders in the US pharma supply chain because it is the only known attempt to organize the full industry around limiting the set of approaches to interoperability for compliance with the 2023 requirements of the DSCSA. Without that, companies would likely invest in solutions that are inherently unable to exchange information with each other, thus violating the DSCSA interoperability requirement and threatening the ability of everyone in the industry to meet the law.

Systech supports and encourages this effort by the PDSA. We offer our considerable experience and technical expertise to help the organization find the right mix of interoperability and flexibility in the industry solution(s) to the 2023 requirements. We intend to participate in this effort, as allowed by the PDSA, and will ensure Systech’s compliance solutions meet the approaches that it develops, for the benefit of our customers and the industry at large.

The PDSA proposal will be just one of the topics covered on our next Systech Global Regulatory Update Webinar on May 8, 2019. Join us for our Regulatory Roundup and then a panel discussion with several global regulatory experts from Excellis Health Solutions. In addition to this new PDSA effort, we will discuss the latest serialization and tracing news from the EU, Russia and elsewhere. We will take questions from the audience and answer them live. Don’t miss this informative free event. Register Now!